Back to resultsEfficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
Primary Purpose
Crohn Disease
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sargramostim (Leukine)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn Disease
Eligibility Criteria
Inclusion Criteria: You must be 18 years or older. You must have active Crohn's disease at the time of screening. You must be 18 years or older. You must have active Crohn's disease at the time of screening. You must be able to give yourself an injection of study drug or have another person who can help you give the injection. You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential. Exclusion Criteria: You may not be pregnant or breastfeeding. You may not have a colostomy or ileostomy. You may not be taking prohibited medications. You may not have had GI surgery or a bowel obstruction in the last 6 months. You may not have ever taken this drug or drugs of similar type in the past.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients achieving clinical response or remission
Secondary Outcome Measures
Proportion of patients achieving clinical response or remission
Full Information
NCT ID
NCT00206713
First Posted
September 13, 2005
Last Updated
December 2, 2013
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00206713
Brief Title
Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
Official Title
Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.
Detailed Description
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sargramostim (Leukine)
Other Intervention Name(s)
BAY86-5326
Intervention Description
6 μg/kg sargramostim administered SC once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered SC once daily during the randomized retreatment phase.
Primary Outcome Measure Information:
Title
Proportion of patients achieving clinical response or remission
Time Frame
At Day 57 of the randomized retreatment phase
Secondary Outcome Measure Information:
Title
Proportion of patients achieving clinical response or remission
Time Frame
At the end of Week 8 of the open-label phase.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
You must be 18 years or older.
You must have active Crohn's disease at the time of screening.
You must be 18 years or older.
You must have active Crohn's disease at the time of screening.
You must be able to give yourself an injection of study drug or have another person who can help you give the injection.
You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.
Exclusion Criteria:
You may not be pregnant or breastfeeding.
You may not have a colostomy or ileostomy.
You may not be taking prohibited medications.
You may not have had GI surgery or a bowel obstruction in the last 6 months.
You may not have ever taken this drug or drugs of similar type in the past.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118-5799
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962-1956
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4399
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
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